Faced with a growing number of suits due to the relationship confirmed by medical studies of new onset diabetes in postmenopausal women taking statins including Lipitor, Pfizer confronted two more deteriorating situations at the end of July, declining revenues, and criminal charges leading to a plea.
On July 30, 2013, the Justice department announced a $490.9 million settlement agreement with Pfizer’s Wyeth unit related to illegal marketing of a kidney-transplant prescription medication, Rapamune (sirolimus). Previously the Food and Drug Administration approved the immunosuppressive therapy for kidney transplant patients but that Wyeth also marketed it on an unapproved basis for other types of organ transplant patients, “which resulted in false Medicare and Medicaid claims”. Originally, whistle-blower suits in 2005 and 2007 led to the DOJ getting involved. The conduct occurred prior to Pfizer’s purchase of Wyeth in 2009.
According to the New York Times, the settlement “also resolves a second, similar whistle-blower suit, includes a criminal fine and forfeiture of $233.5 million, and a civil settlement of $257.4 million with the federal government, all 50 states and the District of Columbia.” Pfizer disclosed the settlement preliminarily, in November 2012 filing with the Securities and Exchange Commission; and US District Judge Vicki Miles-LaGrange in Oklahoma City accepted the plea agreement on July 30, 2013. Reuters quotes FDA Special Agent in Charge Antoinette Henry as saying, “Wyeth’s conduct put profits ahead of the health and safety of a highly vulnerable patient population dependent on life-sustaining therapy.”
Click here to read the full Reuters article: Pfizer settles U.S. marketing case related to Rapamune
Sadly, many drug companies in their zeal to achieve market share and record profits have failed to completely disclose the entire truth about their products, misrepresented the uses to physicians, or engaged in misleading practices. Consumers and their physicians are entitled to know the truth about their drugs and devices. This simply means the whole truth, not just the part that will help sales. As the Lipitor suits grow, and medical studies show an increasing association between statins and diabetes, the truth about Pfizer’s knowledge about its $126 billion product will be further revealed in transparency of the court system.
Pfizer is no stranger to litigation over its products. In September 2009, Pfizer pleaded guilty to the illegal marketing of the arthritis drug Bextra for uses unapproved by the U.S.FDA and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time. This was Pfizer’s fourth such settlement with the U.S. Department of Justice in the previous ten years. It also has been involved in litigation with Blue Cross Blue Shield over allegedly illegally marketing their drugs Bextra, Geodon and Lyricamis and allegations regarding the Bjork-Shiley heart valves
We are currently investigating these cases for a number of women. The Brandi Law Firm is nationally recognized for its long involvement in cases involving defects in drugs or devices. If you or a loved one have taken Lipitor and been diagnosed with Type II Diabetes, based on medical studies, there is a potential claim against the manufacturer. If you would like more information, please contact the Brandi Law Firm by e-mail, or call 415-989-1800 or (800) 481-1615.